# K200695: MATRx plus

- Pathway: 510(k) (Traditional)
- Applicant: Zephyr Sleep Technologies
- Decided: Aug 24, 2020 after 160 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913396 (1992). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191925: MATRx Plus, Zephyr Sleep Technologies (2019) Summary page 4.

## Indications for use
The MATRx plus is indicated for use by a lay person in a home and hospital use under the direction of a Health Care Professional (HCP). MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients. The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study. MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for oral appliance therapy and to recommend a target mandibular position. The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.

Source page: https://510kreport.com/device/K200695
Methodology: https://510kreport.com/methodology